FDA Approves Insulin Degludec/Liraglutide for Type 2 Diabetes
FDA approves Xultophy for type 2 diabetes.
The US Food and Drug Administration (FDA) has approved Xultophy® 100/3.6 (Novo Nordisk)—a combination of insulin degludec 100 units/mL (Tresiba®, Novo Nordisk) and liraglutide 3.6 mg/mL (Victoza®, Novo Nordisk)—to improve glycemic control in type 2 diabetes, according to a press release from the manufacturer.
The agency approved the drug, which is one of a new class of diabetes treatments that combine a basal insulin and a glucagon-like peptide-1 (GLP-1) receptor agonist, as an adjunct to diet and exercise in adults whose diabetes is not adequately controlled on < 50 units of basal insulin daily or <1.8 mg of liraglutide daily.
Xultophy 100/3.6 is administered as a once-daily injection from a prefilled pen and can be taken with or without food. Each 100/3.6-dosage unit contains 1 unit of insulin degludec and 0.036 mg of liraglutide. Starting dose is 16 units (16 units of insulin degludec and 0.58 mg of liraglutide). Maximum dose is 50 units (50 units of insulin degludec and 1.8 mg of liraglutide).
In May 2016, the FDA's Endocrinologic and Metabolic Drugs Advisory Committee unanimously recommended approval of the insulin degludec/liraglutide combination.
The agency based this approval on efficacy and safety data from the first DUAL clinical trial (Dual Action of Liraglutide and Insulin Degludec in Type 2 Diabetes, ClinicalTrials.gov Identifier: NCT01336023), and subsequent related trials in the clinical development program. . In these trials, 1393 adults with type 2 diabetes who had failed to achieve glycemic control with liraglutide or basal insulin therapy were switched to Xultophy 100/3.6. It was found that these patients achieved significant reductions in HbA1c. During the trials, the most common adverse events were nasopharyngitis, headache, nausea, diarrhea, increased serum lipase, and upper respiratory tract infection.
Xultophy 100/3.6 is expected to be available in the United States in the first half of 2017.
“I am excited for this new class of type 2 diabetes medication that can offer patients another treatment option to help them reach their goals,” John Buse, MD, of the University of North Carolina School of Medicine in Chapel Hill, and principal investigator for DUAL II, said in the release.
- Novo Nordisk Receives FDA Approval for Xultophy® 100/3.6 (insulin degludec and liraglutide injection) [news release]. Plainsboro, NJ: Novo Nordisk; November 21, 2016. Accessed November 22, 2016.